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新药研发商Scancell完成高达2500万美元的债务融资,与股权投资相辅相成,为iSCIB1+三期开发提供资金支持

Scancell completes up to US$25 million in debt financing, providing optionality alongside equity investment to finance iSCIB1+ phase 3 development

GlobeNewswire 等信源发布 2026-09-24 05:00

可切换为仅中文


OXFORD, United Kingdom and BURLINGTON, Mass., Sept. 24, 2026 (GLOBE NEWSWIRE) --

英国牛津和美国马萨诸塞州伯灵顿,2026年9月24日(环球新闻社)--

Scancell Holdings plc

Scancell Holdings 有限公司

(AIM: SCLP) (“

(目标:SCLP)(“

Scancell

Scancell

”, or the “

”,或“

Company

公司

”), a late-stage clinical immuno-oncology company developing active immunotherapies designed to enhance anti-tumor immune responses in difficult-to-treat cancers, announced today that, further to its announcement on 23 July 2026 regarding the planned merger with Neuphoria Therapeutics Inc. (“

”),一家处于临床后期、致力于开发旨在增强难治性癌症抗肿瘤免疫反应的主动免疫疗法的免疫肿瘤学公司,今日宣布,继其于2026年7月23日发布的关于与Neuphoria Therapeutics Inc.(“

Neuphoria

新欣快感

”) and financing to conduct the registrational Phase 3 study for iSCIB1+ and a proposed listing on Nasdaq (the “

”)以及为开展 iSCIB1+ 的注册性 III 期临床试验和拟议在纳斯达克上市(“

Merger and Financing Announcement

合并与融资公告

”), it has entered into a loan agreement (the “

”),其已签订一项贷款协议(“

Loan Agreement

贷款协议

”) with certain funds and accounts managed by BlackRock (the “

”)以及由贝莱德管理的某些基金和账户(“

Lender

贷款人

”), for a loan facility of up to US$25,000,000 (the “

”),用于一笔最高金额为2,500万美元的贷款融资(“

Loan Facility”

“贷款融资”

).

)。

The Loan Facility is available in four tranches. For the first three tranches, a portion of each is convertible into Ordinary Shares at the Lender's option, totalling up to US $5,000,000.

该贷款融资分为四个批次。前三个批次中,每一批次的部分金额可由贷款人选择转换为普通股,转换总额最高为500万美元。

The Company intends to draw down US$7,000,000 under the Loan Facility following, and conditional upon, shareholder approval of the Loan Facility at the EGM. Further tranches totalling US$8,000,000 are expected to be available following, and conditional upon, completion of the US Listing Transactions and the expected upcoming opening of the first clinical site for the Phase 3 study for iSCIB1+.

本公司拟在股东于临时股东大会上批准贷款安排后,并以此为前提,提取贷款安排项下的700万美元。此外,预计在美国上市交易完成以及iSCIB1+三期临床试验首个临床中心预期即将开业后,并以此为前提,将可提供总计800万美元的后续分期贷款。

These tranches are expected to be drawn following completion of the US Listing Transactions..

预计这些分期提款将在美国上市交易完成后进行。

The remaining tranche may be drawn until 31 December 2027 subject to a minimum equity fundraising threshold.

在满足最低股权融资门槛的前提下,剩余额度可提取至2027年12月31日。

Dr Phil L’Huillier, CEO of Scancell

菲尔·卢伊耶博士,Scancell 首席执行官

, said: “

,说:“

The debt facility is an important part of an equity and debt package in conjunction with the planned merger that allows Scancell to proceed at pace to initiate and execute the global registrational Phase 3 trial for its lead programme, iSCIB1+.

该债务融资是与计划中的合并相关的股权和债务组合的重要组成部分,使Scancell能够加快进度,启动并执行其核心项目iSCIB1+的全球注册性III期临床试验。

”

”

The Phase 3 trial received IND clearance from the FDA in January 2026. Following Scancell’s recent UK Financing, Phase 3 initiation activities are underway and the Company is on track to commence the trial by the end of 2026. Initial progression free survival (“PFS”) data, which could support accelerated approval under our trial design, is targeted for the second half of 2028..

该III期临床试验于2026年1月获得美国食品药品监督管理局(FDA)的临床试验新药申请(IND)批准。继Scancell近期在英国完成融资后,III期临床试验的启动工作正在推进中,公司有望按计划在2026年底前开始该试验。根据我们的试验设计,可能支持加速批准的初始无进展生存期(“PFS”)数据目标于2028年下半年公布。

Further terms of the Loan Facility

贷款融资的进一步条款

Amounts advanced under the Loan Facility are repayable, following an 18 month interest only period, in 24 equal monthly instalments of principal and interest, or in 18 equal monthly instalments of principal and interest commencing after 24 months if the Company has raised cumulative equity funding of at least US$100,000,000 (inclusive of the proceeds of the UK Placing and the Retail Offer).

在贷款机制下预支的款项,在仅付利息的18个月期间结束后,应以24期等额的本息按月分期偿还;或者,如果公司已筹集累计股权融资至少1亿美元(包括英国配售和零售发行的收益),则应在24个月后开始以18期等额的本息按月分期偿还。

The Loan Facility must be repaid in full on a change of control of the Company..

若公司控制权发生变更,贷款融资必须全额偿还。

Interest on the Term Loan Facilities accrues at 10.50% per annum from the date of advance and is payable in cash on the first day of each month (an “

定期贷款融资的利息自提款日起按年利率10.50%累计,并须于每月首日以现金支付(“

Interest Payment Date

付息日

”). Interest on the Convertible Facilities accrues at a rate of 10.95% per annum and is capitalised and added to the principal amount of the relevant tranche on each Interest Payment Date.

可转换融资的利息按年利率10.95%累计,并在每个利息支付日资本化并计入相关分期的本金金额。

The Lender may convert all or part of the outstanding principal of the Convertible Facilities (including capitalised interest) into Ordinary Shares at a 30% premium to the equity fundraising price announced on 23 July 2026 (subject to adjustment for the Share Consolidation).

贷款人可将可转换融资项下未偿还本金(包括资本化利息)的全部或部分,按较2026年7月23日公布的股权融资价格溢价30%的价格转换为普通股(须就股份合并作出调整)。

The Company may elect to prepay the Loan Facility in full, subject to payment of a prepayment fee.

本公司可选择提前全额偿还贷款融资,但须支付提前还款费。

The Loan Agreement contains customary representations, warranties, covenants and events of default for a facility of this type and size (including a requirement to hold certain minimum amounts of cash subject to security in favour of the Lender). The Company’s obligations are guaranteed by its wholly owned subsidiary, Scancell Limited, and secured over substantially all assets of the Company and Scancell Limited..

该贷款协议包含适用于此类及此规模融资的惯常陈述、保证、承诺和违约事件(包括要求持有一定金额的最低现金,并以贷款人为受益人设定担保)。本公司的义务由其全资子公司Scancell Limited提供担保,并以本公司及Scancell Limited的绝大部分资产作为担保。

Warrants

认股权证

In connection with the Loan Facility, the Company will grant warrants to subscribe for Ordinary Shares (“

就贷款安排而言,本公司将授予认购普通股(“

Warrants

认股权证

”) pro rata to drawdowns under the Loan Facility to Kreos Capital VIII Aggregator SCSp, an affiliate of the Lender (the “

”)按贷款融资项下的提款比例向贷款方的关联方 Kreos Capital VIII Aggregator SCSp 进行(“

Warrantholder

权证持有人

”).

”)。

The number of Ordinary Shares issued to the Warrantholder (“

向权证持有人发行的普通股数量(“

Warrant Shares

认股权证股份

”) will be determined at the point of exercise of the Warrants and will be equal to 4.5% of each drawdown amount divided by the Subscription Price.

”)将在行使权证时确定,并等于每次提款金额除以认购价格的4.5%。

The “

“

Subscription Price

订阅价格

” will be the lowest price paid per share in the Financing (subject to adjustment for the Share Consolidation), or if the Private Placement does not complete, [the lower of (a) the lowest price paid in any future equity financing round by the Company and (b)] the 30-day VWAP per Ordinary Share following an announcement that the Private Placement will not complete.

”将为融资中每股支付的最低价格(须就股份合并进行调整),或者,如果私募配售未完成,则为[(a) 公司在未来任何一轮股权融资中支付的最低价格与(b)]在宣布私募配售将不会完成之后普通股的30日成交量加权平均价中的较低者。

The number of Warrant Shares and/or the Subscription Price are subject to customary adjustments. The Warrants are exercisable at any time up to the earlier of (i) 10 years from the date of the Loan Facility or (ii) a sale of the Company..

认股权证股份数量和/或认购价格须按惯例进行调整。认股权证可在以下较早日期之前的任何时间行使:(i) 贷款安排日起满10年之日;或 (ii) 公司出售之日。

Shareholder Approval

股东批准

Drawdowns under the Loan Facility and the issue of the Warrants are conditional upon shareholder approval at the EGM, [which the Company expects to hold in October 2026]. Further details of the Loan Facility and the EGM will be contained in the Circular and Notice of General Meeting, which will be announced and distributed to shareholders in due course..

贷款融资项下的提款及认股权证的发行须以股东在临时股东大会上批准为条件,[公司预计将于2026年10月举行该会议]。有关贷款融资及临时股东大会的进一步详情将载于通函及股东大会通告中,该等文件将在适当时候公布并分发给股东。

Capitalised terms used but not otherwise defined in this announcement have the same meaning as defined in the Merger and Financing Announcement.

本公告中使用但未另行定义的大写术语,其含义与《合并及融资公告》中的定义相同。

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR) as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018.

本公告包含《欧盟第596/2014号条例》(市场滥用条例)第7条所规定的内幕信息,该条例凭借《2018年欧盟(退出)法》构成英国国内法的一部分。

The person responsible for arranging for the release of this announcement on behalf of Scancell is Phillip L'Huillier, Chief Executive Officer.

代表Scancell负责安排发布本公告的人员是首席执行官Phillip L'Huillier。

About iSCIB1+

关于 iSCIB1+

iSCIB1+ is a DNA ImmunoBody

iSCIB1+ 是一种 DNA 免疫体

®

®

in development for the treatment of melanoma. Administered by needle-free intramuscular injection, iSCIB1+ encodes an antibody targeting the melanoma-associated antigens gp100 and TRP-2, priming high-avidity T cells to generate a robust and durable anti-tumor response. In the Phase 2 SCOPE trial in first-line advanced melanoma, iSCIB1+ in combination with ipilimumab and nivolumab demonstrated a PFS of 77% at 22 months in the target HLA population, with no increase in checkpoint inhibitor-related toxicities.

正在开发用于治疗黑色素瘤。iSCIB1+通过无针肌肉注射给药,编码一种针对黑色素瘤相关抗原gp100和TRP-2的抗体,能够启动高亲和力T细胞,从而产生强效且持久的抗肿瘤反应。在针对一线晚期黑色素瘤的II期SCOPE临床试验中,iSCIB1+与伊匹木单抗和纳武利尤单抗联用,在目标HLA人群中显示出22个月时无进展生存率(PFS)为77%,且未增加与检查点抑制剂相关的毒性。

iSCIB1+ has demonstrated a favorable safety profile and clinically meaningful activity as a monotherapy in Phase 1 and in combination with checkpoint inhibitors in the Phase 2 SCOPE trial in advanced melanoma..

iSCIB1+在晚期黑色素瘤的Ⅰ期单药治疗和Ⅱ期SCOPE联合检查点抑制剂试验中,均显示出良好的安全性特征和具有临床意义的活性。

iSCIB1+ has been granted Fast Track Designation for the treatment of advanced melanoma from the FDA. The registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma has received an IND clearance from the FDA and CTA from the UK MHRA and is expected to begin in the second half of 2026.

iSCIB1+已获得美国食品药品监督管理局(FDA)授予的用于治疗晚期黑色素瘤的突破性疗法认定。iSCIB1+在晚期黑色素瘤患者中的注册性III期临床试验已获得美国FDA的临床试验新药申请(IND)批准以及英国药品和保健品管理局(MHRA)的临床试验授权(CTA),预计将于2026年下半年启动。

A Phase 2 trial of iSCIB1+ in patients with neo/adjuvant melanoma is planned for the first half of 2027..

计划于2027年上半年开展一项针对新辅助/辅助治疗黑色素瘤患者的iSCIB1+二期临床试验。

iSCIB1+ is an investigational medicinal product. It has not been approved by the MHRA, the FDA or any other regulatory authority for the treatment of melanoma or any other indication, and its safety and efficacy have not been established.

iSCIB1+ 是一种研究用药品。它尚未获得英国药品和保健品管理局(MHRA)、美国食品药品监督管理局(FDA)或任何其他监管机构批准,用于治疗黑色素瘤或任何其他适应症,其安全性和有效性也尚未确立。

Scancell (LSE:SCLP; www.scancell.co.uk)

Scancell(伦敦证券交易所代码:SCLP;网址:www.scancell.co.uk)

is a late-stage clinical biotechnology company developing targeted, off-the-shelf, active immunotherapies, generated by the ImmunoBody

是一家处于临床后期阶段的生物技术公司,致力于开发由ImmunoBody平台生成的靶向、现成型主动免疫疗法。

®

®

and Moditope

以及 Moditope

®

®

platforms, designed to stimulate durable anti-tumor responses. The lead product, iSCIB1+, is a DNA ImmunoBody

平台,旨在激发持久的抗肿瘤反应。主要产品iSCIB1+是一种DNA ImmunoBody

®

®

that has demonstrated a favorable safety profile and clinically meaningful activity both as a monotherapy, in a Phase 1 trial, and in combination with checkpoint therapies in a Phase 2 trial in patients with melanoma. Modi-1 is a Moditope peptide currently being evaluated in a Phase 2 study in head & neck and renal cancers.

该药物在黑色素瘤患者中开展的1期单药治疗和2期与检查点抑制剂联合治疗的临床试验中,均显示出良好的安全性特征和具有临床意义的活性。Modi-1是一种Moditope肽,目前正在头颈部癌和肾癌的2期研究中进行评估。

In addition, Scancell is advancing a pipeline of high affinity GlyMab.

此外,Scancell 正在推进一系列高亲和力 GlyMab 的研发管线。

®

®

antibodies targeting tumor specific glycans, two of which have been licensed for further development to Genmab A/S, an international biotechnology company and global leader in the antibody therapeutics space.

靶向肿瘤特异性聚糖的抗体,其中两种已授权给国际生物技术公司、抗体治疗领域的全球领导者 Genmab A/S 进行进一步开发。

Additional Information

附加信息

In connection with the proposed business combination (Business Combination) between Neuphoria Therapeutics Inc. (Neuphoria) and Scancell, Scancell and Neuphoria intend to file with the U.S. Securities and Exchange Commission (SEC) a Registration Statement on Form F-4 (Registration Statement) containing a preliminary proxy statement of Neuphoria and a preliminary prospectus of Scancell, and after the Registration Statement is declared effective, Neuphoria will mail a definitive proxy statement/prospectus related to the proposed Business Combination to its stockholders.

就Neuphoria Therapeutics Inc.(“Neuphoria”)与Scancell之间拟议的业务合并(“业务合并”),Scancell和Neuphoria打算向美国证券交易委员会(SEC)提交一份F-4表格注册声明(“注册声明”),其中包含Neuphoria的初步委托书声明和Scancell的初步招股说明书。在注册声明被宣布生效后,Neuphoria将向其股东邮寄与拟议业务合并相关的最终委托书声明/招股说明书。

This communication does not contain all the information that should be considered concerning the proposed Business Combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed Business Combination. Neuphoria’s stockholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and the amendments thereto and the definitive proxy statement/prospectus and other documents filed in connection with the proposed Business Combination, as these materials will contain important information about Scancell, Neuphoria and the proposed Business Combination.

本通讯并未包含就拟议业务合并而言应予考虑的所有信息,亦不构成任何投资决策或任何其他与拟议业务合并相关决策的基础。建议Neuphoria的股东及其他利益相关方在可得时阅读初步委托书/招股说明书及其修订案、最终委托书/招股说明书以及与拟议业务合并相关的其他文件,因为这些材料将包含有关Scancell、Neuphoria及拟议业务合并的重要信息。

When available, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to stockholders of Neuphoria as of a record date to be established for voting on the proposed Business Combination. Stockholders of Neuphoria will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a written request to: Neu.

在可行的情况下,拟议业务合并的最终代理声明/招股说明书及其他相关材料将邮寄给在为拟议业务合并投票而确定的记录日期登记在册的Neuphoria股东。Neuphoria股东还将能够在初步代理声明/招股说明书、最终代理声明/招股说明书及其他向美国证券交易委员会(SEC)提交的文件可供查阅后,通过访问SEC网站www.sec.gov或向Neu发出书面请求,免费获取这些文件的副本。

Participants in the Solicitation

招标参与者

Neuphoria and its directors and executive officers may be deemed participants in the solicitation of proxies from Neuphoria’s stockholders with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests in Neuphoria is contained in Neuphoria’s proxy statement on Schedule 14A for the 2025 Annual Meeting, which was filed with the SEC on November 24, 2025 and is available free of charge at the SEC’s web site at www.sec.gov, or by directing a written request to Neuphoria Therapeutics Inc, 100 Summit Dr, Burlington, Massachusetts 01803.

Neuphoria 及其董事和高级管理人员可能被视为就业务合并事宜向 Neuphoria 股东征集投票代理权的参与者。这些董事和高级管理人员的姓名清单及其在 Neuphoria 中的权益描述,载于 Neuphoria 为 2025 年年度会议提交的 Schedule 14A 委托声明书中。该文件已于 2025 年 11 月 24 日向美国证券交易委员会(SEC)备案,可免费访问 SEC 网站 www.sec.gov 获取,或通过向 Neuphoria Therapeutics Inc.(地址:100 Summit Dr, Burlington, Massachusetts 01803)发送书面请求获取。

Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed Business Combination when available..

有关此类参与者权益的额外信息将在拟议业务合并的代理声明/招股说明书(如有)中载明。

Scancell and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Neuphoria in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination when available..

Scancell 及其董事和高级管理人员也可能被视为参与向 Neuphoria 股东征集与拟议业务合并相关的代理权。此类董事和高级管理人员的名单以及他们在拟议业务合并中的权益信息,将在拟议业务合并的代理声明/招股说明书(一旦可供查阅时)中列载。

Forward-Looking Statements

前瞻性陈述

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate”, “aim”, “continue”, “target” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法》安全港条款所定义的“前瞻性陈述”。诸如“可能”、“将”、“相信”、“预期”、“计划”、“预计”、“旨在”、“继续”、“目标”等词语及类似表述(以及其他提及未来事件或情形的词语或表述)均用于识别前瞻性陈述。

All statements, other than statements of historical facts, included in this press release are forward-looking statements..

本新闻稿中包含的所有陈述,除历史事实陈述外,均为前瞻性陈述。

These statements include, but are not limited to, statements regarding: expectations regarding clinical benefits and availability of Scancell’s product candidates, including iSCIB1+ in advanced melanoma; expectations regarding the design, progress, timing, enrolment, randomization, scope, expansion, and results of Scancell’s existing and planned clinical trials, including Scancell's Phase 3 registrational trial of iSCIB1+ in advanced melanoma and Phase 2 monotherapy trial of iSCIB1+ in patients with neo/adjuvant melanoma; the expected submission of clinical trial applications or investigational new drug applications; the timing and sufficiency of clinical trial outcomes to support potential approval of any of Scancell’s product candidates; the potential regulatory approval; and the timing, ability to close and anticipated benefits of the proposed Business Combination.

这些陈述包括但不限于以下方面的陈述:对Scancell候选产品(包括用于晚期黑色素瘤的iSCIB1+)的临床获益和可用性的预期;对Scancell现有及计划开展的临床试验的设计、进展、时间安排、受试者入组、随机化、范围、扩展及结果的预期,其中包括iSCIB1+用于晚期黑色素瘤的III期注册临床试验以及iSCIB1+用于新辅助/辅助治疗黑色素瘤患者的II期单药治疗临床试验;预计提交的临床试验申请或新药研究申请;临床试验结果支持Scancell任何候选产品潜在获批的时间安排和充分性;潜在的监管批准;以及拟议业务合并的完成时间、完成能力及预期获益。

Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond Scancell’s control.

任何前瞻性陈述均基于管理层对当前未来事件的预期和信念,并受到多种风险和不确定性的影响,这些风险和不确定性可能导致实际事件或结果与前述前瞻性陈述中所述或暗示的内容存在重大且不利差异,其中许多因素超出了Scancell的控制范围。

These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions, including as a result of health epidemics or pandemics, war in Ukraine, the conflict in the Middle East, or global geopolitical tension, on Scancell’s business, financial position, strategy and anticipated milestones, including Scancell's ability to conduct ongoing and planned clinical trials; Scancell’s ability to obtain a clinical supply of current or future product candidates; Scancell’s ability to obtain regulatory approval of its product cand.

这些风险和不确定性包括但不限于:宏观经济状况恶化(包括由健康疫情或大流行病、乌克兰战争、中东冲突或全球地缘政治紧张局势所导致)对Scancell的业务、财务状况、战略及预期里程碑的影响,其中包括Scancell进行正在进行和计划中的临床试验的能力;Scancell获得当前或未来候选产品临床供应的能力;以及Scancell获得其候选产品监管批准的能力。

No Offer

无报价

This communication is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

本沟通内容仅供信息参考,不构成根据拟议交易或以其他方式出售任何证券的要约或购买任何证券的要约邀请;在根据相关州或司法管辖区的证券法进行注册或资格认定之前,若在此类州或司法管辖区内进行此类要约、要约邀请或销售属违法行为,则不得在此类州或司法管辖区内销售任何此类证券。

No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended..

除通过符合经修订的《1933年证券法》要求的招股说明书外,不得进行任何证券发行。

For more information please contact:

如需更多信息,请联系:

Scancell Holdings plc

Scancell Holdings 有限公司

+44 (0) 20 3709 5700

+44 (0) 20 3709 5700

Phil L’Huillier, CEO

菲尔·卢伊利耶,首席执行官

Panmure Liberum

潘穆尔自由

(Nominated Adviser and Joint Broker)

(提名顾问及联席保荐人)

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

Emma Earl, Will Goode, Mark Rogers

艾玛·厄尔、威尔·古德、马克·罗杰斯

WG Partners LLP (Joint Broker)

WG Partners LLP(联合经纪商)

Claes Spang

克拉斯·斯庞

+44 (0) 20 3705 9330

+44 (0) 20 3705 9330

Investor and media relations

投资者与媒体关系

Mandeep Sehmi

曼迪普·塞米

+44 (0) 20 3709 5700 mandeepsehmi@scancell.co.uk

+44 (0) 20 3709 5700 mandeepsehmi@scancell.co.uk